LW Scientific, Inc.

Basic Information

• Brand Name: LW Scientific, Inc.
• Primary DI: 00664816002278
• Version / Model: I4S-EPB4-IPL3
• Catalog Number: I4S-EPB4-IPL3
• Company Name: LW SCIENTIFIC, INC.
• Labeler DUNS: 785335381
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: 86194fc2-758e-465c-99fd-30b65117ec6c

Device Description

I-4 Infinity Epi-fluorescent Microscope, PLAN, binocular, LED, (LED 485nm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IBK	Microscope, Fluorescence/U.V.	Pathology	864.3600	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35796	Fluorescence light microscope	A magnification instrument in which light (typically ultraviolet) that has been absorbed by the specimen and re-emitted at a longer wavelength is observed (as visible light) so that the specimen is visible through the eyepiece. This device is typically used in the laboratory for histopathology and microbiology, commonly in conjunction with fluorescent dyes. Appropriate filters are used to select the correct wavelength of incoming beam to excite the fluorescent compound and eliminate the unwanted incident wavelength from the fluorescent light source (i.e., the specimen).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00664816002278	GS1